{"id":198173,"date":"2024-10-19T12:36:55","date_gmt":"2024-10-19T12:36:55","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir62296-2009\/"},"modified":"2024-10-25T05:10:07","modified_gmt":"2024-10-25T05:10:07","slug":"aami-tir62296-2009","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir62296-2009\/","title":{"rendered":"AAMI TIR62296 2009"},"content":{"rendered":"

This Technical Report contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1. This Technical Report is primarily intended to be used by manufacturers of MEDICAL ELECTRICAL EQUIPMENT; test houses and others responsible for assessment of compliance with IEC 60601-1; and those developing subsequent editions of IEC 60601-1. The object of this Technical Report is to make the recommendations\/interpretations developed by the experts in IEC\/SC 62A\/WG 14 available to those interested in the application of the second edition of IEC 60601-1.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/IEC TIR62296:2009, Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
6<\/td>\nCONTENTS <\/td>\n<\/tr>\n
8<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
10<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of ANSI\/AAMI adoption of IEC\/TR 62296:2009 <\/td>\n<\/tr>\n
12<\/td>\nFOREWORD <\/td>\n<\/tr>\n
14<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
15<\/td>\n1 Scope and object
1.1 Scope
1.2 Object <\/td>\n<\/tr>\n
16<\/td>\n2 Recommendations
2.1 Summary of all recommendations prepared by SC\u00a062A\/WG 14 <\/td>\n<\/tr>\n
18<\/td>\n2.2 Recommendation sheets
2.2.1 Separation: Reliability of component impedance <\/td>\n<\/tr>\n
20<\/td>\n2.2.2 Separation: Non-complying creepage distance and air clearances <\/td>\n<\/tr>\n
21<\/td>\n2.2.3 Mains supply transformers: Overload test <\/td>\n<\/tr>\n
22<\/td>\n2.2.4 Mains supply transformers: Short circuit and overload tests <\/td>\n<\/tr>\n
23<\/td>\n2.2.5 Creepage distance and air clearances: Values <\/td>\n<\/tr>\n
24<\/td>\n2.2.6 Dielectric strength <\/td>\n<\/tr>\n
25<\/td>\n2.2.7 Failure of components: Evidence of reliability <\/td>\n<\/tr>\n
26<\/td>\n2.2.8 ENCLOSURES and protective covers <\/td>\n<\/tr>\n
27<\/td>\n2.2.9 INTERNALLY POWERED EQUIPMENT: 110 % of the maximum supply voltage <\/td>\n<\/tr>\n
28<\/td>\n2.2.10 Creepage distances and air clearances: Values under 1\u00a0mm <\/td>\n<\/tr>\n
29<\/td>\n2.2.11 Separation: Secondary circuit impedance limit LEAKAGE CURRENT <\/td>\n<\/tr>\n
30<\/td>\n2.2.12 ENCLOSURES and PROTECTIVE COVERS: Lampholder\/switching device <\/td>\n<\/tr>\n
31<\/td>\n2.2.13 Fixing, prevention of maladjustment: Torque test <\/td>\n<\/tr>\n
32<\/td>\n2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries <\/td>\n<\/tr>\n
33<\/td>\n2.2.15 Excessive temperatures: Ambient temperatures <\/td>\n<\/tr>\n
34<\/td>\n2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS <\/td>\n<\/tr>\n
35<\/td>\n2.2.17 ENCLOSURE and protective covers: EQUIPMENT in ambulances <\/td>\n<\/tr>\n
36<\/td>\n2.2.18 Dielectric strength: Voltages appearing from external sources <\/td>\n<\/tr>\n
37<\/td>\n2.2.19 Testing switch mode power supply units (SMPSU) <\/td>\n<\/tr>\n
39<\/td>\n2.2.20 Failure of an electrical component: Time periodicity for detection <\/td>\n<\/tr>\n
40<\/td>\n2.2.21 Environmental conditions: Compliance paragraph <\/td>\n<\/tr>\n
41<\/td>\n2.2.22 Limitation of voltage and\/or energy: Capacitance <\/td>\n<\/tr>\n
42<\/td>\n2.2.23 LEAKAGE CURRENTS: Presence of 45 k\u03a9 resistor in Figure 21 <\/td>\n<\/tr>\n
43<\/td>\n2.2.24 Humidity preconditioning treatment: Exception from requirement <\/td>\n<\/tr>\n
44<\/td>\n2.2.25 Dielectric strength: EQUIPMENT containing floating circuits <\/td>\n<\/tr>\n
45<\/td>\n2.2.26 General requirements for tests: Measurement uncertainty <\/td>\n<\/tr>\n
46<\/td>\n2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES: Interpolated values <\/td>\n<\/tr>\n
47<\/td>\n2.2.28 Overheating: Change of load resistance <\/td>\n<\/tr>\n
48<\/td>\n2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of externalprotective earth <\/td>\n<\/tr>\n
49<\/td>\n2.2.30 Rechargeable batteries: No OPERATOR\/USER maintenance <\/td>\n<\/tr>\n
50<\/td>\n2.2.31 Isolation from the SUPPLY MAINS: Symbol for single pole switch <\/td>\n<\/tr>\n
51<\/td>\n2.2.32 Sequence of testing: Clause 52 before Clause 19 <\/td>\n<\/tr>\n
52<\/td>\n2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from INTERNALLY POWEREDEQUIPMENT <\/td>\n<\/tr>\n
53<\/td>\n2.2.34 Marking on the outside of EQUIPMENT: Type and rating of fuses <\/td>\n<\/tr>\n
54<\/td>\n2.2.35 Excessive temperatures: APPLIED PARTS not intended to supply heat <\/td>\n<\/tr>\n
55<\/td>\n2.2.36 Mains supply transformers: Use of PTCs as protective devices <\/td>\n<\/tr>\n
56<\/td>\n2.2.37 Components and general assembly: Reliability of components <\/td>\n<\/tr>\n
57<\/td>\n2.2.38 Definition of APPLIED PART: EQUIPMENT worn by PATIENTS <\/td>\n<\/tr>\n
58<\/td>\n2.2.39 Construction: Triple insulated winding wire <\/td>\n<\/tr>\n
59<\/td>\n2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGEDISTANCES and AIR CLEARANCES <\/td>\n<\/tr>\n
60<\/td>\n2.2.41 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGEDISTANCES and AIR CLEARANCES \u2013 POWER SUPPLY CORDS <\/td>\n<\/tr>\n
61<\/td>\n2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or electronic file format <\/td>\n<\/tr>\n
62<\/td>\n2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements for lithium batteries <\/td>\n<\/tr>\n
63<\/td>\n2.2.44 Dielectric strength: Differences between B-d and B-e <\/td>\n<\/tr>\n
64<\/td>\n2.2.45 Excessive temperatures: Thermocouple instead of resistance method <\/td>\n<\/tr>\n
65<\/td>\n2.2.46 Mains fuses and OVER-CURRENT RELEASEs: Fuses in CLASS II EQUIPMENT <\/td>\n<\/tr>\n
66<\/td>\n2.2.47 Plug in power supply <\/td>\n<\/tr>\n
67<\/td>\n2.2.48 Connecting cords between EQUIPMENT parts: Other applications <\/td>\n<\/tr>\n
68<\/td>\n2.2.49 MULTIPLE PORTABLE SOCKET-OUTLET <\/td>\n<\/tr>\n
69<\/td>\n2.2.50 Separation, DEFIBRILLATION-PROOF APPLIED PART: multiple APPLIED PARTS <\/td>\n<\/tr>\n
70<\/td>\n2.2.51 Separation, APPLIED PART: Hand held flexible shafts <\/td>\n<\/tr>\n
71<\/td>\n2.2.52 Protective earthing: No-load voltage of 6 V maximum <\/td>\n<\/tr>\n
72<\/td>\n2.2.53 Foot-operated control devices: Protection against entry of liquids <\/td>\n<\/tr>\n
73<\/td>\n2.2.54 Mains supply transformers <\/td>\n<\/tr>\n
74<\/td>\n2.2.55 Dielectric strength: Reliability of components to bridge A-a2 and B-a <\/td>\n<\/tr>\n
75<\/td>\n2.2.56 Dielectric strength: A-e in switch mode power supply units (SMPSU) <\/td>\n<\/tr>\n
76<\/td>\n2.2.57 Dielectric strength: Connection of 12 V dc negative side to enclosure <\/td>\n<\/tr>\n
77<\/td>\n2.2.58 Dielectric strength: Voltages appearing on SIP\/SOP <\/td>\n<\/tr>\n
78<\/td>\n2.2.59 APPLIED PART: EQUIPMENT without APPLIED PART <\/td>\n<\/tr>\n
79<\/td>\n2.2.60 Scope: Other than MEDICAL ELECTRICAL EQUIPMENT in contact with the body of aperson <\/td>\n<\/tr>\n
80<\/td>\n2.2.61 Markings: AC symbol <\/td>\n<\/tr>\n
81<\/td>\n2.2.62 Interruption of power supply: Characteristics of interruption <\/td>\n<\/tr>\n
82<\/td>\n2.2.63 Reference voltage: Different reference voltages in the same circuit <\/td>\n<\/tr>\n
83<\/td>\nBibliography <\/td>\n<\/tr>\n
85<\/td>\nIndex of Terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/IEC TIR62296:2009 – Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2009<\/td>\n86<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198176,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198173","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198173","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198176"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198173"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198173"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198173"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}